The present invention relates generally to medical treatments. More specifically, the present invention relates to medical connectors for use in medical treatments, such as Peritoneal Dialysis (“PD”).
Due to disease, insult or other causes, a person's renal system can fail. In renal failure of any cause, there are several physiological derangements. The balance of water, minerals and the excretion of daily metabolic load is no longer possible in renal failure. During renal failure, toxic end products of nitrogen metabolism (urea, creatinine, uric acid, and others) can accumulate in blood and tissues.
Kidney failure and reduced kidney function have been treated with dialysis. Dialysis removes waste, toxins and excess water from the body that would otherwise have been removed by normal functioning kidneys. Dialysis treatment for replacement of kidney functions is critical to many people because the treatment is life saving. One who has failed kidneys could not continue to live without replacing at least the filtration functions of the kidneys.
PD uses a dialysis solution or dialysate, which is infused into a patient's peritoneal cavity. The dialysate contacts the patient's peritoneal membrane in the peritoneal cavity. Waste, toxins, and excess water pass from the patient's bloodstream through the peritoneal membrane and into the dialysate. The transfer of waste, toxins, and water from the bloodstream into the dialysate occurs by diffusion and osmosis because there is an osmotic gradient across the peritoneal membrane. The spent dialysate is drained from the patient's peritoneal cavity to remove the waste, toxins and water from the patient. New dialysate replaces the spent dialysate and the process repeats.
During dialysis therapy, a dialysis fluid exchange generally includes draining spent dialysis fluid from the peritoneal cavity and filling the peritoneal cavity with fresh dialysate. Keeping track of the amounts or volumes of dialysis solution drained from and supplied to the peritoneal cavity is important for proper dialysis therapy: A typical amount of dialysate solution drained from and supplied to the peritoneal cavity of an adult during an exchange can be roughly two to three liters. Dialysis fluid exchanges have been performed manually, usually by the patient, or automatically, by an automated dialysis machine.
In the manual PD technique, known as Continuous Ambulatory Peritoneal Dialysis (“CAPD”), a catheter is implanted into the peritoneal cavity of the patient. A dialysis solution (“dialysate”) is introduced through the catheter into the peritoneal cavity of a patient. Typically, a container of the dialysate connects to a connector, which in turn couples to the catheter. To start the flow of dialysate into the peritoneal cavity, a clamp on a tube connecting the container to the connector is loosened or a valve is opened. In many cases the container is located vertically above the patient and gravity fed into the peritoneal cavity.
In the Automated Peritoneal Dialysis technique (“APD”), dialysis machines use one or more fluid pumps to perform the dialysate exchanges. The pump pumps spent dialysate fluid out of the peritoneal cavity during the drain mode and pumps dialysate into the cavity during the fill mode.
In either PD technique, once the dialysate reaches the patient, dialysis of urea, toxic waste and the like takes place between the dialysate and the blood passing through blood vessels in the peritoneum, which is the lining of the peritoneal cavity. The dialysate remains in the peritoneal cavity for several hours. Thereafter, the dialysate is removed from the peritoneal cavity carrying with it diffused breakdown products from the blood. In CAPD, one method for removing the spent dialysate is to lower the dialysate container outside of the body and let the dialysate drain into the container.
The spent container is disconnected and discarded, wherein a new container of dialysate fluid is attached and the process is repeated. This process may be repeated several times or continuously repeated. Because many patients perform the PD (CAPD or APD) procedure themselves, it is important that the connector which connects the dialysate container to the catheter is easy to use and provides a secure connection.
A frequent problem that occurs with PD is peritoneal infection or peritonitis which can readily occur given the repeated disconnecting and reattaching of the dialysate containers. Peritonitis results if connections are made between the peritoneal catheter and the connector communicating with the dialysis container in a maimer that permits even a very small number of microorganisms to enter the catheter. The microorganisms will be flushed into the peritoneal cavity. Peritonitis can occur even when extreme caution is observed in making and unmaking the connections. Peritonitis can be painful and can temporarily diminish the hydraulic permeability of the peritoneal membrane, rendering the renal treatment less successful.
Methods to prevent peritonitis have included thoroughly cleansing the connector and the tube connecting the dialysate container before the connection is made. For instance, the connector can be immersed in povidone iodine, betadine or other type of disinfectant. These methods however are messy, time consuming, effort consuming, inconsistent and may be subject to overkill in order to achieve consistently effective results. Hospital workers, as another precaution, typically wear sterile rubber gloves to prevent or guard against any possible peritoneal invasion of bacteria. However, the spread of contamination can still occur due to, for example, a cut in the glove or other like condition.
Accordingly, the frequent connections that must be made and broken between the catheter residing in the peritoneal cavity and a succession of dialysate containers has created a need to ensure the sterilization of connectors used in performing CAPD and APD. Attempts have been made to saturate an absorbent material with disinfectant and dispose the material in the connector such that it contacts the tube/connector interface. A need still exists however to improve the efficiency, effectiveness and cost of providing sterile connections for PD.
A continuing need therefore exists to provide a simple and effective method and apparatus for performing PD, including CAPD and APD both in hospitals and at a patient's home.